1    NAME OF THE MEDICINAL PRODUCT

Chloramphenicol 1% w/w Antibiotic Eye Ointment

Golden Eye Antibiotic 1.0% w/w Chloramphenicol Eye Ointment

2    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Chloramphenicol 1% w/w

Also contains wool fat. For full list of excipients, see 6.1

3    PHARMACEUTICAL FORM

Eye Ointment Smooth yellow ointment.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Treatment of acute bacterial conjunctivitis.

4.2    Posology and method of administration

Administration: For topical ocular use.

The ointment is applied into the space between the lower eyelid and the eye.

Adults (including elderly people) and children aged 2 years and over:

If using just the eye ointment, apply about 1 cm of ointment to the affected eye(s) 3 to 4 times a day.

If using chloramphenicol eye drops during the day and the eye ointment at night - apply the ointment at night, before going to bed.

The course of treatment is 5 days.

4.3    Contra-indications

Hypersensitivity to chloramphenicol or to any of the ingredients.

Family or personal history of blood dyscriasis including aplastic anaemia.

4.4    Special warnings and precautions for use

The eye ointment should not be used in children under the age of 2, since there have been very rare reports of leukaemiae and grey baby syndrome.

Prolonged use of chloramphenicol eye drops is not advisable.

Chloramphenicol eye ointment should not be used for more than 5 days at a time except on the advice of a doctor.

The label will state:

•    Consult your doctor immediately if :

♦    symptoms worsen at any time

♦    no improvement within 48 hours.

•    Discard after a 5 day course of treatment.

•    Do not use if allergic to:

♦    chloramphenicol

♦    the other ingredients

Chloramphenicol eye ointment should not be recommended under the following circumstances (in these circumstances patients should be referred to their doctor):

•    Severe pain within the eye

•    Disturbed vision

•    Photophobia

•    The pupil looks unusual

•    The eye looks cloudy

•    Associated pain or swelling around the eye or face

•    The patient has had conjunctivitis previously in the recent past

•    The patient has glaucoma

•    The patient has dry eye syndrome

•    The patient has an eye injury

•    Suspected foreign body in the eye

•    The patient is already using other eye ointments or eye drops

•    The patient has had eye surgery or laser treatment in the last 6 months

If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished the eye ointment.

The product contains wool fat (lanolin) which may cause local skin reactions (e.g. contact dermatitis).

4.5 Interactions with other medicinal products and other forms of interaction

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6    Use during pregnancy and lactation

Chloramphenicol may be absorbed systemically following the use of the eye ointment. Chloramphenicol does cross the placenta and enter breast milk. Therefore chloramphenicol eye ointment should not be used during pregnancy and breastfeeding.

4.7    Effects on ability to drive and use machines

May cause transient blurring of vision on instillation of the ointment. User should not drive or operate hazardous machinery unless vision is clear.

4.8    Undesirable effects

Local effects:

Sensitivity reactions such as transient irritation, burning, stinging, itching and dermatitis have been reported.

Systemic effects:

Very rarely cases of major adverse haematological events (bone marrow depression, aplastic anaemia and death) have been reported following ocular use of chloramphenicol.

4.9    Overdose symptoms, emergency procedures, antidotes

Refer to a doctor in the event of accidental ingestion of the eye ointment.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group (AITC code): S01 AA01, antibiotics for topical use.

Chloramphenicol is a broad spectrum antibiotic which has activity against many types of Gram-positive and Gram-negative bacteria. Chloramphenicol is not effective against fungi, protozoa, and viruses.

Acute bacterial conjunctivitis is commonly caused by staphylococci or streptococci in adults, and Haemophilus influenzae and Moraxella catarrhalis (formerly known as Branhamella catarrhalis) particularly in children.

Chloramphenicol is effective against Gram-positive cocci including staphylococci such as Staph. epidermidis and some strains of Staph. aureus, and streptococci such as Str. pneumoniae, Str. pyogenes, and the viridans streptococci.

Gram-negative cocci such as Haemophilus influenzae are usually highly sensitive. Moraxella catarrhalis, a Gram-negative aerobic diplococcus frequently found as a commensal of the upper respiratory tract, is also highly sensitive.

5.2    Pharmacokinetic properties

Evidence suggests that chloramphenicol is absorbed systemically via topical ocular administration. Any chloramphenicol that is absorbed will be widely distributed in the body tissues and fluids. It is found in cerebrospinal fluid, is secreted in saliva, with the highest concentrations occurring in the kidneys and liver.

Chloramphenicol also diffuses across the placenta into the foetal circulation and into breast milk.

Chloramphenicol is excreted chiefly in the urine as the glucuronide with small amounts being excreted via the bile and faeces. It has a reported half life of 1.5 to 5 hours which is increased in patients with liver impairment and neonates to between 24 and 28 hours in the latter.

5.3    Preclinical safety data

No additional data of relevance to the prescriber.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid paraffin, wool fat, yellow soft paraffin.

6.2    Major incompatibilities

None known

6.3    Shelf Life

36 months unopened 28 days once opened

6.4    Special precautions for storage Do not store above 25°C.

6.5    Nature and contents of container

Pre-printed collapsible polyethylene / aluminium foil laminated tube with integral nozzle and a tamper evident polyethylene cap. Each tube is packed into a carton.

Contents: 4g of product.

6.6    Special precautions for disposal

Sterile until opened.

Although the shelf life once opened is 28 days, patients should be advised to discard the medicine after a 5 day course of treatment.

7    MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd

Trading as iCare

Bampton Road

Romford

Essex

RM3 8UG

8    MARKETING AUTHORISATION NUMBER(S)

PL 0156/0105

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18/09/2007

10 DATE OF REVISION OF THE TEXT

22/07/2016